Generex Biotechnology Initiates Peptide Manufacturing for Ii-Key- SARS-CoV-2 Peptide Vaccine Against the COVID-19 Pandemic - Seite 2

Generex CEO, Joseph Moscato said, “We have been working diligently over the last two months to rapidly respond to the coronavirus pandemic, because our Ii-Key peptide technology offers true promise for an effective and safe COVID-19 vaccine. Highlighting the potential for our Ii-Key-SARS-CoV-2 “Complete Vaccine”, Generex has obtained letters of support from key, industry leading partners to provide their expertise, experience, facilities and infrastructure for the development and manufacturing of an Ii-Key-SARS-COV-2 vaccine.  We have contracted PPD, a recognized leading CRO to provide comprehensive, turnkey clinical and regulatory services, including regulatory submissions, site preparation, clinical testing, data management, protocols and reports required to maximize the speed and path to licensure. Additionally, we are planning GMP vaccine production with industry leaders in GMP peptide synthesis, including Polypeptide Laboratories (the manufacturers of our AE37 Ii-Key-HER2 immuno-oncology product), Bachem, and Corden Pharma who are on board to provide clinical trial material and kilogram scale commercial manufacturing.  We also have support from international leaders, Ajinomoto and Thermo-Fisher for fill/finish and quality control, ensuring both capacity and redundancy to deliver on large scale vaccination requirements. Further, we have obtained a letter of support from 3M to evaluate the use of their new vaccine adjuvant in the formulation of the Ii-Key peptide vaccines for the comprehensive clinical program that was outlined in our proposal.”

Mr. Moscato continued, “Because Generex’ subsidiary NuGenerex Immuno-Oncology has a long history of developing the Ii-Key peptide vaccine technology to rapidly respond to potential pandemic threats, we have been able to rapidly mobilize our efforts to help respond to the COVID-19 global pandemic.  And, as shown in the recently published positive results from our Phase II trial of AE37 in the prevention of breast cancer recurrence in hard to treat patients, the Ii-Key activates the T-Cell response against the HER2 antigenic epitope to which it is attached. The authors point out the benefit of such a complete immune response combining CD8+ and CD4+ activation may not only induce an immediate cell mediated cytolytic response versus tumor antigens but may also induce T-Helper cell mediated long-term immunity to protect against tumor recurrence. The activation of a complete immune response against coronavirus antigens modulated by the Ii-Key is what sets us apart from others in the field and makes us confident in our plans to deliver a COVID-19 vaccine with our Ii-Key-SARS-CoV-2 peptide vaccine development program. We will keep our investors informed as the development progresses.”